Ashwagandha and the current regulatory situation in Europe [Interview]

“The challenge is that ashwagandha is available in so many forms. Different extractions methods, different plant parts, and in different concentrations. This has, of course, created a challenge for the authorities. A problem that could have been avoided if there had been a high-quality monograph or pharmacopeia describing how ashwagandha should be standardised and which parts should be used and for what.

“I don't see any real reason to use the leaf internally as a supplement for healthy, stressed people. As soon as the leaf is added, it changes the relationships between active ingredients, which alter both characteristics and safety.

“Even if the risk of adverse reactions is still small with a leaf extract, it’s there. And that's bad enough. If, on the other hand, you take a full spectrum root extract, the risk of side effects is close to zero.

“What is also common, is the addition of piperine to ashwagandha, which is unnecessary since ashwagandha-root extract is easily absorbed from the beginning. The only thing piperine does, is to increase risk for drug interaction and side effects.

“The industry does not always see the consequence of what it does. They’re just trying to create something propriety and new, not considering that the safety properties change at the same time.”

“Absolutely, if they can supply enough acceptable safety data. The challenge is that there is very few – if any – real, long-term safety data on the leaf that I know of. Unfortunately, it’s not enough to have a few studies on mice. It’s a good start but when it comes to propriety blends, then higher demands are made.

“That's why I think KSM-66 is the leader again. They have already generated impressive long-term safety data and reproduction studies on mice and rats on 200 times the normal dose (2,000 mg/kg). They also have 25 gold standard, double-blind, placebo-controlled studies over eight to 12 weeks, including on safety. Plus, another 20 ongoing studies, which also include long-term safety on humans. Nobody else comes close. And what is important, they can show that KSM-66 is mimicking the root, which means that they also can lean on 5,000 years of extensive use.

“I want to underline that I have nothing against the leaves, but I want good and safe products on the market that can be defended against authorities. Products with minimal risk of side effects.

“In Scandinavia, we are fighting very hard to convince the authorities that their conclusions are based on incorrect facts and that a well-defined root extract has no safety risk. We are together with the Swedish supplier organisation arguing for the root – not only KSM-66 – even though most of the available safety documentation is based on KSM-66.”

“Denmark is one of the strictest countries in Europe regarding supplements. In many ways, they have legislation that I support; for instance, in Denmark, you need to register a supplement before you launch. In most European countries, you don't need to. The company is responsible for its products.

“The background to the first risk assessment that was written in Denmark in 2008 was that a woman in Belgium was suspected to have developed thyroid toxicity after eating an unknown ashwagandha extract. That triggered the Danish authorities to start looking at ashwagandha.

“However, this report did not mention that the woman had been pregnant, which is the most common cause to develop thyroid toxicity. So, Denmark took a position to forbid ashwagandha in 2010/11, a position they have maintained.

“In 2020 the situation got worse when Denmark issued a new risk evaluation. It was very ambitious, but it has a crucial problem: they didn’t differentiate between the root, leaf, stem, or berries. As a matter of fact, they made the conclusion that ashwagandha root could harm sexual and thyroid hormones based on older mice studies on parts other than the root, mainly the leaf and stem.

“Sweden, which works very closely with Denmark, took one look at the conclusions, which said that there was no safe, lower limit of ashwagandha, and posted it on their website. Short thereafter, Finland also adopted the same stance.”

“The German risk assessment is from 2012 and is based on old facts. So, it’s not worth considering.

“When it comes to supplements, legislation is not great in the EU. As a result, most countries have their own application of the guidelines.

“Ashwagandha is still not a major supplement in Europe, although it is growing rapidly. So, for authorities in different countries, it's not a big thing to challenge ashwagandha.

“What is regrettable is that authorities, without a sound ground, are worrying a lot of people who feel the benefits of ashwagandha such as reduced anxiety, more energy, better sexual health etc.

“I think it's amazing that sales of ashwagandha are as high as they are in Scandinavia, and growing, despite the warnings. This really shows the strength of ashwagandha. Consumers are content and feel great eating ashwagandha; they don't want to be without it.

“I am positive that with the growing number of new studies that demonstrate long-term safety, the authorities will change their standpoint. We must remember that they don't do this to be mean - they are protecting consumers. The science was not there from the beginning, but it is now - thanks to KSM-66.”